MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dehydration (1807); Low Blood Pressure/ Hypotension (1914)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

A follow up mdr will be submitted upon completion of the plant's investigation.There is a probable temporal association between the pd therapy with the liberty cycler and the patient experiencing shortness of breath/fatigue during a significant hypotensive episode (with systolic bp in the 70¿s) during outpatient cardiology appointment.However, it is unknown when the pt.Completed their last ccpd treatment (treatment information unknown).Furthermore, the pt.Has known/pre-existing significant cardiac comorbidities (with unknown medical/cardiac management) which potentially may have been a contributory factor.Based on the information received, actual causality cannot be determined.Should additional information become available this clinical investigation will be re-evaluated.

Event Description

Upon review of the medical records it was indicated on (b)(6) 2017, the patient experienced a significant hypotensive episode with shortness of breath/fatigue during an outpatient cardiology appointment which required an emergency room visit.It was noted the patient was treated with fluid replacement in the er and was subsequently deemed medically stable for discharge home same day.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

Upon review of the medical records it was indicated on (b)(6) 2017, the patient experienced a significant hypotensive episode with shortness of breath/fatigue during an outpatient cardiology appointment which required an emergency room visit.It was noted the patient was treated with fluid replacement in the er and was subsequently deemed medically stable for discharge home same day.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6734459
• MDR Text Key: 80750096
• Report Number: 2937457-2017-00610
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 07/26/2017
• Supplement Dates FDA Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention